Catalog Number

AK-01000-J

Brand Name

ARROW

Version/Model Number

IPN032615

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K870572,K870572

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

56820d71-60ea-486c-8a4e-1fe769b5cc3d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

30801902002694

Quantity per Package

10

Contains DI Package

00801902002693

Package Discontinue Date

July 31, 2017

Package Status

Not in Commercial Distribution

Package Type

Case